Purpose

COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.

Condition

Eligibility

Eligible Ages
Between 0 Years and 22 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged 0 to 22 years of age - SARS-CoV-2 infection documented by RNA RT-PCR detection - Admitted to an acute care facility - Ability of patient or guardian to provide consent and assent (if applicable); if patient is intubated assent may be waived

Exclusion Criteria

  • Pregnancy/ breast feeding - Medical condition that increases the risk of plasma infusion - Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products). Inclusion criteria for infusion: - Severe COVID-19 disease, OR - Moderate disease with a risk of progression to severe or life threatening disease, OR - Severely immunocompromised patient with any illness attributed to COVID-19 disease requiring inpatient care. Exclusion to infusion: - Pregnancy/ breast feeding - Medical condition that increases the risk of plasma infusion - Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Convalescent Plasma (CP)
Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered
  • Biological: Convalescent Plasma (CP)
    Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria), an ABO compatible product will be identified. The CP dose administered will be 10mL/kg/dose (up to 2 units per dose) times two doses per patient for a total dose of 20 mL/kg. Patients will be followed for adverse events and clinical response. Research blood testing will be obtained prior to infusion (baseline) and serially weekly afterwards until clinical resolution. Patients will receive 2 doses equaling 20 mL/kg (if available) of ABO compatible CP over 24-48 hours if they do not experience grade 3-5 adverse events that are possible, probably, or definitely attributed to CP after the first dose. Patients will be followed for adverse events for a minimum of 28 days after the last infusion of CP.
  • Drug: Standard COVID-19 therapies
    If clinical status permits, administration of additional COVID-19 therapies should be delayed 48 hours or more from CP infusion completion. Supportive care will be administered by best clinical practice.

Recruiting Locations

More Details

NCT ID
NCT04458363
Status
Completed
Sponsor
Emory University

Detailed Description

COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.